Cleft Lip and Palate Treatment Outcomes Study

Infants with cleft lip and palate often benefit from presurgical infant orthopedic treatment before surgical repair. Multiple standard of care approaches are selected based on each infant's clinical presentation and family circumstances. This prospective observational cohort study will evaluate clinical outcomes, treatment efficiency, and family burden using routinely collected clinical records and photographs to support individualized, evidence-based PSIO treatment planning.

NCT Number	NCT07687537
Lead Sponsor	University of Florida
Conditions	Cleft Lip and Palate
Enrollment	100 participants
Start Date	2026-08-01
Primary Completion	2028-07-31 (estimated)
Study Completion	2029-07-31 (estimated)
Updated on ClinicalTrials.gov	2026-07-07